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Health·P Space·Evidence-backed problem·Published 2026-07-12

Linq ii¿ insertable cardiac monitor: FDA malfunction report involving AI

Abstract: The FDA received a malfunction report involving Linq ii¿ insertable cardiac monitor, made by Medtronic singapore operations. It was reported that true pause episodes were rejected as false by the artificial intelligence (ai) algorithm. it was further reported that the implantable cardiac monitor (icm) detected false ventricular tachycardia (vt) episodes. the icm remains in use. no patient complications have been reported as a result of this event.

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Linq ii¿ insertable cardiac monitor: FDA malfunction report involving AI

"Onassis Cardiac Surgery Center, Athens, Greece" by Tilemahos Efthimiadis is licensed under CC BY 2.0. To view a copy of this license, visit https://creativecommons.org/licenses/by/2.0/.

The quick read

The FDA received a malfunction report for the Linq ii insertable cardiac monitor made by Medtronic singapore operations. According to the report, the device's AI algorithm rejected true pause episodes as false and detected false ventricular tachycardia episodes. The monitor remains implanted and in use, and the report states no patient complications have been reported as a result of this event.

Accurate pause and tachycardia detection matters because clinicians rely on these classifications for diagnosis and management decisions, so missed true events and false alerts could affect care if confirmed. What remains uncertain is whether this single report reflects a systematic issue, as the text notes it is part of MAUDE surveillance and should be read as a signal for follow-up, not a clinical conclusion or verified incidence rate, and causality is not established.

Main points
  • Device identified as Linq ii insertable cardiac monitor made by Medtronic singapore operations.
  • Report states the icm remains in use after the reported malfunction.
  • Report states no patient complications have been reported as a result of this event.
  • Source notes the report is part of FDA's MAUDE surveillance data and should be read as a signal for follow-up.
Problem

An FDA malfunction report described the Linq II insertable cardiac monitor's AI algorithm rejecting true pause episodes and generating false ventricular tachycardia detections, with no complications reported to date.

Sources

Reader signal

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The debate